MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-03-30 for BREATH TECH HYPERINFLATION SYSTEM HS34051 manufactured by Ventlab Llc..
[41480671]
The bag kept falling off in the neonatologists hand while he was attempting to resuscitate the baby. It was confirmed that there was patient involvement with no harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246980-2015-00028 |
| MDR Report Key | 5535732 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-30 |
| Date of Event | 2016-02-19 |
| Report Date | 2016-03-02 |
| Date Reported to Mfgr | 2016-03-02 |
| Date Mfgr Received | 2016-03-02 |
| Date Added to Maude | 2016-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598350 |
| Manufacturer G1 | VENTLAB LLC. |
| Manufacturer Street | 2710 NORTHRIDGEDR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATH TECH HYPERINFLATION SYSTEM |
| Generic Name | HYPERINFLATION SYSTEM |
| Product Code | NHK |
| Date Received | 2016-03-30 |
| Model Number | HS34051 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTLAB LLC. |
| Manufacturer Address | 2710 NORTHRIDGEDR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-30 |